MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number RONYX20022UX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx drug-eluting stent was intended to be used during a procedure to treat a lesion in the distal lad, exhibiting moderate tortuosity and moderate calcification.The lesion was 75% stenosed.No damage was noted to device packaging, and the device was inspected without issues noted.The lesion was not pre-dilated and the device did not pass through a previously deployed stent.No resistance was noted when advancing the stent, and excessive force was not used during delivery.It is reported that after the initial inflation and delivery system removal, the physician noticed the stent had migrated from the distal lad to the proximal lad.The stent was inflated with a non-compliant balloon dilation catheter to 2.5mm.Afterward the stent once again migrated into the left main.The physician had to post-dilate the stent to 3.0mm and leave it in the left main.The original distal lesion was not treated.No further patient injury reported.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10046236
• MDR Text Key: 190604810
• Report Number: 9612164-2020-01855
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX20022UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention